Emerald Bioscience Corporate Presentation January, 2020 - OTCQB: EMBI
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Emerald Bioscience Corporate Presentation January, 2020 OTCQB: EMBI
Legal Disclaimer This presentation contains “forward-looking statements”, including statements regarding Emerald Bioscience, Inc. and its subsidiaries, within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. All of the statements in this presentation, whether written or oral, that refer to expected or anticipated future actions and results of Emerald Bioscience are forward-looking statements. In addition, any statements that refer to expectations, projections, or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements reflect our current projections and expectations about future events as of the date of this presentation. Emerald Bioscience cannot give any assurance that such forward-looking statements will prove to be correct. The reader is cautioned not to place undue reliance on these forward-looking statements. The information provided in this presentation does not identify or include any risk or exposures, of Emerald Bioscience that would materially adversely affect the performance or risk of the company. For a description of the risks and uncertainties related to the busi ness of Emerald Bioscience, see our Annual Report on Form 10-K filed with the Securities and Exchange Commission and our subsequent periodic reports filed with the Securities and Exchange Commission. All information contained in this presentation is provided as of the date of the presentation and is subject to change withou t notice. Neither Emerald Bioscience, nor any other person undertakes any obligation to update or revise publicly any of the forward-looking statements set out herein, whether as a result of new information, future events or otherwise, except as required by law. This presentation shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities of Emerald Bioscience, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior t o registration or qualification under the securities laws of any such jurisdiction. This is presented as a source of information and not an in vestment recommendation.
Improving health through
cannabinoid-based
targeted therapeutics
BRIAN MURPHY, MD, MPH, MBA
Chief Executive Officer
2019 Key Corporate Milestones
• Secured “all fields” licenses from the University • The company reported the exercise of 40.8 million warrants by
of Mississippi for THCVHS and CBDVHS Emerald Health Sciences, which offset $4.08 million owed under
permitting development for any indication, using the Multi Draw Credit Agreement, dated as of October 5, 2018.
any formulation via any route of administration, for
human and veterinary use • Upon exercise of the warrants, the aggregate reduced
outstanding principal balance excluding discounts under the Multi
• DEA ruled CBDVHS was not a controlled Draw Credit Agreement is $2,014,500.
substance
• Dr. Avtar Dhillon, offered his resignation as the Chairman of the
• Dr. Dennis Kim assumed Chief Medical Officer role Board and the position of Chairman of the Finance and Business
and Ms. Alice Chen joined the company as Development Committee. Dr. Dhillon plans to devote more time to
Executive Director of Clinical Operations Emerald Health Sciences where he serves as both CEO and
Director
• Recruited a globally recognized expert panel for • The Board appointed Punit Dhillon, an existing member of the
the ophthalmology advisory board Board, as Chairman of the Board and as Chairman of the Finance
and Business Development Committee, to fill the vacancies in
• The Board approved the company name change to such offices created by the resignation of Dr. Dhillon.
EMBI Pharmaceuticals
emeraldbio.life P.4
NB1111
For the Treatment of
Glaucoma
Lowering Intra-ocular Pressure
Providing neuroprotection to optic nerve
Glaucoma: A Significant Global Unmet Medical Need
Non-responder market where >50% of patients require two or more therapies
NB1111
H i g h U n me t C a n n a b i n o i d s D e mo n s t r a t e
Large Market Opportunity
Medical Need Efficacy & Neuroprotection
• A leading cause of irreversible • Cannabinoids have exhibited
• $4.8 billion globally and growing with
blindness in the US due to death of neuroprotective qualities in vitro and in
aging populations (CAGR 6.6%)
retinal ganglion cells (RGS) vivo (multiple animal species) related to
preservation of the optic nerve
• Approaching $3 billion U.S.
• Progressive disease requiring multiple
medications to manage • THC has demonstrated activity to
• Non-responder-market; majority of
lower IOP via multiple routes of
patients prescribed 2 or more meds
administration
• Greater than 35 million TRx (U.S.)
* Market Scope, 2018
emeraldbio.life P.6
Asian Glaucoma Markets: Cannabinoid-Based
Neuroprotection Could Secure Major Market Share
Prevalence of Normal Tension Glaucoma (NTG) as a % of Primary Open Angle Glaucoma (POAG) in Key
Asian Countries
Japan China is home to 18% of world’s glaucoma
78-92% patients while India accounts for 15%
China
85-90% US/EU
30-32%
India
52-82%
Normo-tension glaucoma is characterized by glaucomatous changes to optic
nerve without elevated intraocular pressure (IOP)
emeraldbio.life Source: Published Glaucoma Prevalence Studies. P.7
NB1111 (THCVHS) Achieves Tissue Penetration in
Organs Regulating IOP in Rabbit Glaucoma Model
No THC or 11-OH-THC was detected in the plasma of study animals even after 5 days
of dosing (ng sensitivity level of detection)
emeraldbio.life P.8
Evolution of Cannabinoid
Delivery into the Eye
emeraldbio.life P.9IOP-Time profiles Obtained with Δ9-THC-Val-HS, Timolol
Maleate, and Pilocarpine in Rabbit Glaucoma Model
Abbreviations: IOP = intraocular pressure; THC-Val-HS = tetrahydrocannabinol-valine-hemisuccinate; ug = microgram; w/v = weight by volume.
Source: Adelli et al, 2017
emeraldbio.life P.10Evolution of NB1111 formulation: pathway to longer IOP
lowering activity in normotensive animal model
NE – nanoemulsion; Toc – Tocrisolve (marketed premade blank emulsion); Carbopol 940 – viscosity enhancer
emeraldbio.life P.11Average IOP vs Time Profile of Single Doses of Latanoprost
(0.005%) vs THC-Val-HS NEC (1%) vs Timolol (0.25%)
20
19
Normotensive rabbit model
18
17
IOP (mmHg)
16
15
14
13
0 60 120 180 240 300 360 420 480
Time (min)
Average of Latanoprost Average NEC THC-VHS 1.0% Average Timolol
Abbreviations: NES THC-VHS and THC-Val-HS NEC = ∆9-tetrahydrocannabinol-valine-hemisuccinate and ∆9-
tetrahydrocannabinol-valine-hemisuccinate nanoemulsion, respectively; min = minute(s).
emeraldbio.life Source: D.8.6, In-house data, Interim Report, Delta-9 THC-VHS in Glaucoma, 18 Mar 2019. P.12Five-day multiple dosing IOP impact of THCVHS formulations
vs. latanoprost in a normotensive rabbit model
Both THCVHS formulations deliver superior IOP lowering capability and
pharmacodynamics when compared to latanoprost
20.0
18.0
IOP (mmHg)
16.0
14.0
12.0
0 60 120 180 240 300 360 420 480
Time (min)
Figure 4: Day 1, 3 and 5 average IOP vs time profile of 1.0% THC-VHS NE, 0.005% Latanoprost, 1.0%
THC-VHS NEC in New Zealand albino rabbits after multi-dose treatment (mean ± SEM, n=6)
emeraldbio.life P.13Active moiety of NB1111, THC, significantly lowered biomarkers associated with
inflammation, fibrosis, and neovascularization in ex vivo human tissue model*
• MAPK/ERK** pathway is
implicated in anti-fibrosis
activity of THC
• THC in the eye exhibited a bi-
phasic response seen outside
the eye in other organs
• IOP lowering capability of
THC may be multi-factorial,
including vasodilatory, anti-
inflammatory, and anti-fibrotic
responses
• The data implicate a role of
the endocannabinoid system
• Presented at AAO, 2019 in the feedback cascade of
• **MAPK: mitogen-activated protein kinase
• **ERK: extra-cellular signal regulated kinase
the inflammatory and fibrosis
emeraldbio.life
cytokine cascades
P.14Neuroprotection with a CB-1 agonist: WIN55212
A= control/Tocrisolve
B= ischemia/placebo
C= WIN55212
D= ischemia + WIN 55212
E= WIN 55212+ AM251
F= ischemia + WIN55212 +
AM251
emeraldbio.life P.15NB1111 Development Plan
Ocular Development Timelines
• Initiate Phase 1 SAD study (healthy volunteers)
Near-Term Value • Data analysis SAD study H2’20
Creating Milestones for • Initiate Phase 2a study (MAD)
NB1111 • Initiate cannabinoid neuroprotection study
• Open EMBI Australia (completed 2019) H1’20
• Announce Australian CRO (completed 2019)
• Finalize manufacturing scale-up THCVHS and associated
formulation fill/finish
• Initiate animal ocular study combination therapy for
glaucoma study
emeraldbio.life P.17CBDVHS Proprietary Analog of CBD
CBDVHS: DEA Determination, Key Attributes, Patent Findings
DEA: CBDVHS is not a regulated chemical nor controlled substance
CBDVHS patents currently granted in South Africa, Australia, and New Zealand
Is more chemically stable than CBD
EMBI plans to continue
ocular development of
Early animal studies Distribution into multiple organ compartments CBDVHS for potential use in
conducted at the
conditions in both the
University of Mississippi
anterior compartment
have determined CBDVHS:
Exhibits enhanced uptake in the liver (uveitis and dry eye
syndrome) and
retinopathies like macular
Crosses the blood:brain barrier more effectively than degeneration in the
CBD posterior compartment
Does not readily convert to THC when exposed to an
acidic environment
emeraldbio.life P.19In vitro neurology study and ex vivo human ocular studies completed for CBDVHS: support move into in vivo animal studies Stemonix Neurological Studies Glauconix Ocular Studies • CBDVHS is pharmacologically • CBDVHS is pharmacologically and and therapeutically distinct from therapeutically distinct from CBD CBD • CBDVHS significantly lowered • CBDVHS displayed antiseizure biomarkers of inflammation and activity in epilepsy model parallel fibrosis to that observed with CBD • CBDVHS was 100x more potent • Animal studies warranted to than CBD in this biomarker model assess potency vs bioavailability • CBDVHS had no effect on IOP of CBDVHS and CBD • This study has been accepted for • Study to be conducted at CHOP presentation at ARVO to be held in in murine epilepsy model May, 2020 in Baltimore emeraldbio.life P.20
Development Timelines
• Initiate assessment of impact on liver H2’20
Near-Term Value
• Explore extra-ocular formulations
Creating Milestones for • Develop clinical plan for possible ocular and extra-
CBDVHS ocular uses
• Manufacture cGMP API (2019-2020)
• Initiate study of CBDVHS impact on IOP (2019)
• Initiate study of CBDVHS antiviral study H1’20
• Initiate study of CBDVHS impact on hepatic tissue
• Continue formulation work of ocular CBDVHS
• Initiate murine epilepsy study CHOP-Philadelphia
• Initiate animal study assessing analgesia MOA
• Initiate preclinical bioavailability/PK animal
studies
emeraldbio.life P.21Pipeline emeraldbio.life P.22
Capitalization
La r g est S h a r eh o ld er :
O T CBQ All S h a r eh o ld er s
Em er a ld H ea lth S c ien c es
Common Shares
182.9 M 113.9 M (62%)
Outstanding
Options & Warrants 29.7 M 7.5 M (25%)
Convertible Debt Shares 5.0 M2
5.0 M (100%)
On As If Converted Basis
Fully Diluted 217.6 M 126.5 M (58%)
Market Cap $29.3 M1
Long Beach, California
Base of Operations
&Oxford, Mississippi
* 1 Based on 20/`01/10 OTCQB per share price of $.16
2 Based on $2,014,500 of outstanding principal balance and accrued interest outstanding as of 20/01/10 on multi-draw credit facility which is convertible at $.40 per share
emeraldbio.life P.23Management BRIAN MURPHY, MD, MPH, MBA – Chief Executive Officer, Director Dr. Murphy has two decades of experience in drug development and evaluation, both from the academic and industry perspective. He most recently served as the CMO of Eiger Biosciences. Previously, Dr. Murphy was CMO at Valeant Pharmaceuticals International (VRX) where his responsibilities also included oversight of Global Medical Affairs, Clinical Development, Biostatistics, and Pharmacovigilanc e. Dr. Murphy also served as Medical Director, then VP of Marketing and Commercial Strategy of Hepatology for InterMune, Inc. (ITMN). Prior to InterMune, Dr. Murphy was Medical Director of North America for Antivirals/Interferons/Transplant at Hoffmann-LaRoche. Murphy is board-certified in internal medicine and completed his residency at Tufts-New England Medical Center. He served as Chief Medical Resident in the Boston University Internal Medicine program. He went on to complete parallel fellowship tracts at Harvard Medical School (HMS) and the Massachusetts General Hospital in medicine and clinical epidemiology. He also completed a fellowship in Medical Ethics at HMS-Brigham and Women’s Hospital. Dr. Murphy earned his MD, MPH (general public health), and MS (pharmacology) degrees from New York Medical College and is a graduate of the Harvard School of Public Health (MPH in Health Policy and Management). He earned his MBA at the Columbia University Graduate School of Business. DOUG CESARIO, MBA – Chief Financial Officer Mr. Cesario brings over 15 years of financial and operational experience across many industries. Prior to joining EMBI, Mr. Cesario served as Chief Financial Officer of Kaiser Permanente Foundation Hospitals and Health Plan in the Orange County, California marketplace, where he managed the financial performance of the health system with an operating budget of over $1 billion per year. Previously Mr. Cesario held various financial leadership positions, including founder of Community Capital Advisory Group, a real estate advisory and investment company; director of Skye Automotive, a private equity fund; and corporate finance associate at both full service and boutique investment banking firms. Mr. Cesario earned a Master’s in Business Administration from the UCLA Anderson School of Management. DENNIS KIM, MD, MBA – Chief Medical Officer Dr. Kim is a physician and biotechnology executive with over twenty years of experience in drug and product development as well as corporate strategy in biotech and medical technology. Prior to joining Emerald, Dr. Kim was Chief Medical Officer at Zafgen, Senior Vice President of Medical and Clinical Affairs at Orexigen Therapeutics, Chief Medical Officer at EnteroMedics, and Executive Director of Corporate Strategy at Amylin Pharmaceuticals. He holds an MD from the University of Health Sciences, The Chicago Medical School, an MBA from UCSD Rady School of Management, and a BS in Biology from the University of California-Los Angeles (UCLA). In addition to being board-certified in internal medicine, Dr. Kim completed the Endocrinology and Metabolism Specialty Fellowship Training Program at the UCSD School of Medicine.
Board of Directors and Strategic Advisors
Punit Dhillon Jim Heppell, Esq DONALD I. ABRAMS, M.D.
Executive Chairman Board of Directors Scientific Advisor
Mr. Dhillon is the Co-founder and Mr. Heppell is the former founder, Chief, Hematology/Oncology at
Director of OncoSec Medical, Inc. and CEO and director of BC Advantage UCSF
the former Vice President of Finance Life Sciences I fund and is Cancer and Integrative Medicine
and Operations at Inovio currently a director at a number of specialist with research interests
Pharmaceuticals, Inc. He has extensive public and private life science in the development of anti-cancer
management companies. Mr. Heppell has therapeutics and palliative care
experience spanning corporate extensive experience in corporate medicines.
finance, M&A and strategy finance law.
implementation.
MAHMOUD A. ELSOHLY, PHD
Scientific Advisor
World’s foremost expert on the science of
cannabinoids. 300+ scientific
publications . Research professor at The
University of Mississippi.
emeraldbio.life P.25Ophthalmology Advisory Board
Louis Pasquale, MD
Jeffrey Goldberg, MD, PhD Professor of Ophthalmology
Department of Ophthalmology, Stanford
Professor of Ophthalmology at the
Professor and Chair of Ophthalmology Icahn School of Medicine at Mount
and Director of the Spencer Center for Sinai in New York City and Site
Vision Research at the Byers Eye Chair of the Department of
Institute at Stanford University. Ophthalmology at Mt. Sinai Hospital
and Vice Chair of Translational
Ophthalmology Research for the
Mount Sinai Healthcare System.
Robert Ritch, MD
Professor of Ophthalmology, Mt. Sinai College
of Medicine
Dr. Robert Ritch holds the Shelley and
Steven Einhorn Distinguished Chair and is
Surgeon Director Emeritus; Chief of
Glaucoma Services; Director of International
Ophthalmic Education and Director of
Glaucoma Research at the New York Eye &
Ear Infirmary of Mount Sinai, New York
City.
emeraldbio.life P.26THANK YOU
T O L E A R N M OR E P L E A S E C ON T A C T :
invest@emeraldbio.life
OTCQC: EMBI
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